BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERA DR

    MDR report key: 4162868 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19331
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    February 1, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 5024M-52 LEAD IMPLANTED (B)(6) 1995. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINIC WAS UNABLE TO INTERROGATE DEVICE IN (B)(6) 2014 DUE TO END OF LIFE (EOL). THE PATIENT HAD NOT HAD THEIR DEVICE CHECKED FOR THE PREVIOUS FOURTEEN YEARS. THE PHYSICIAN OPTED TO PLACE AN EVENT MONITOR ON THE PATIENT TO DETERMINE IF A PACEMAKER WAS STILL NECESSARY. IT WAS ALSO REPORTED THAT ABOUT FIVE MONTHS LATER THE PATIENT EXPERIENCED DIZZINESS AT HOME WITH STRIPS ON THE EVENT MONITOR REVEALING 6 SECOND PAUSES. A NEW DEVICE WAS IMPLANTED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639460 THERA DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7940B

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R 4524-45 LEAD